FDA Adverse Event
Malfunction
Summary report: N
V200 VENTIALTOR
MDR report key: 3951063
·
Received July 22, 2014
Report
- Report Number
- 2031642-2014-00710
- Event Type
- Malfunction
- Date Received
- July 22, 2014
- Report Date
- June 25, 2014
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- PMA / PMN Number
- K102054
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUPPLEMENTAL 2 REPORT
Additional Manufacturer Narrative · 1
SUPPLEMENTAL REPORT
Additional Manufacturer Narrative · 1
DEVICE EVALUATION AND SERVICE PENDING.
Description of Event or Problem · 1
THE INTERNATIONAL CUSTOMER REPORTED THE VENTILATOR CANNOT WORK ON AC POWER DURING NORMAL VENTILATION OPERATION. THE CUSTOMER REPORTED THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS PATIENT HARM. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE. EVALUATION OF DEVICE AND SERVICE IS PENDING.
Description of Event or Problem · 1
THE POWER SUPPLY WAS REPLACED. FACTORY ANALYSIS REVEALED A BRIDGE RECTIFIER SHORT THAT RESULTED IN THE REPORTED POWER ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED PATIENT INVOLVEMENT WITH NO HARM TO THE PATIENT. FOLLOW-UP ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT EVALUATION OF THE DEVICE AND REPAIR INFORMATION; NO RESPONSE RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 427644 | V200 VENTIALTOR | VENTILATOR, CONTINUOUS | CBK | RESPIRONICS CALIFORNIA, INC. | V200 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |